Irritable Bowel SyndromeNCT03675100
Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS
A study testing colonoscopic mucosal biopsy in people with Irritable Bowel Syndrome and Tight Junction Alteration, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
To evaluate the role of neurotrophic factors (NGF, GDNF, TRPV-1), to quantity tight junction proteins (ZO-1, occludin, claudin) and cytokines (IL-8, TNF-a, IL-1b) in the colonic mucosa of IBS patients and also clarify sex differences in the pathophysiology of IBS. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Tight Junction Alteration, Pathophysiology
- What is being tested?
- colonoscopic mucosal biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Control group Those who were between 18 and 80 years old and did not have any abnormalities in colonoscopy
- Irritable bowel syndrome group Patients who diagnosed as irritable bowel syndrome according to the ROME III criteria
Who cannot join
- history of IBD
- abdominal operation
- severe systemic disease
- malignancy,
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Expression of Neurotrophic Factors, Tight Junction Proteins, and Cytokines According to the Irritable Bowel Syndrome Subtype and Sex
To evaluate the role of neurotrophic factors (NGF, GDNF, TRPV-1), to quantity tight junction proteins (ZO-1, occludin, claudin) and cytokines (IL-8, TNF-a, IL-1b) in the colonic mucosa of IBS patients and also clarify sex differences in the pathophysiology of IBS.
- Being tested
- colonoscopic mucosal biopsy
- Keywords
- Irritable bowel syndrome, Subtype, Tight junction, Sex
- Medical subject headings
- Irritable Bowel Syndrome, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopic mucosal biopsyProcedure or surgery
colonoscopic mucosal biopsy was undertaken for every participant
| Study group | Role | What they receive |
|---|---|---|
| IBS group | Sham comparator | Patients who were diagnosed with IBS according to the ROME III criteria. Colonoscopic mucosal biopsy was undertaken for every subject. Receives: Procedure: colonoscopic mucosal biopsy |
| Control group | Active comparator | Healthy participants who have no gastrointestinal symptoms and no colonoscopic abnormality. Colonoscopic mucosal biopsy was undertaken for every subject. Receives: Procedure: colonoscopic mucosal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa
real-time qPCR
Measured: up to 24 weeks
Secondary outcomes (2)
ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa
real-time qPCR and Western blot
Measured: up to 24 weeks
IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa
real-time qPCR
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study startJun 2009
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675100
- Sponsor's protocol ID
- B-1305/202-003
- Status last verified
- Mar 2020
- First submitted
- 11 Sep 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Neurotrophic Factors, Tight Junction Proteins, and Cytokines According to the Irritable Bowel Syndrome Subtype and Sex
- ClinicalTrials.gov ID
- NCT03675100
- Acronym / sponsor ID
- B-1305/202-003
- Keywords
- Irritable bowel syndrome, Subtype, Tight junction, Sex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the role of neurotrophic factors (NGF, GDNF, TRPV-1), to quantity tight junction proteins (ZO-1, occludin, claudin) and cytokines (IL-8, TNF-a, IL-1b) in the colonic mucosa of IBS patients and also clarify sex differences in the pathophysiology of IBS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS group | Sham comparator | Procedure: colonoscopic mucosal biopsyPatients who were diagnosed with IBS according to the ROME III criteria. Colonoscopic mucosal biopsy was undertaken for every subject. |
| Control group | Active comparator | Procedure: colonoscopic mucosal biopsyHealthy participants who have no gastrointestinal symptoms and no colonoscopic abnormality. Colonoscopic mucosal biopsy was undertaken for every subject. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Control group Those who were between 18 and 80 years old and did not have any abnormalities in colonoscopy
- Irritable bowel syndrome group Patients who diagnosed as irritable bowel syndrome according to the ROME III criteria
Key exclusion criteria (4 listed)
- history of IBD
- abdominal operation
- severe systemic disease
- malignancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopic mucosal biopsycolonoscopic mucosal biopsy was undertaken for every participant | Procedure or surgery | Control group, IBS group |
Primary outcome
NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa
Time frame: up to 24 weeks
real-time qPCR
2 secondary outcomes
ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa
Time frame: up to 24 weeks
IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayoung Kim, Professor principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopic mucosal biopsy in people with Irritable Bowel Syndrome and Tight Junction Alteration, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.